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Elucidating the Necessary Active Components of Training (ENACT)

Primary Purpose

Alzheimer Disease, Cognitive Change, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BUD1
BUD2
TDD1
TDD2
CSA10
CSA20
CSA30
CSA40
Sponsored by
Clemson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alzheimer Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Phase 1:

    • Age 55-85 community-dwelling adults
    • Written informed consent obtained
    • No reported evidence of or diagnosis of dementia/Alzheimer's Disease; score of 5 or greater on the MIS-t administered during phone screening
    • Willing and able to participate in the up to 9 months of the study duration
    • Is proficient in written and spoken English
  • Phase 2:

    • All Phase 1 criteria plus willingness and ability to provide two blood samples at baseline and posttest

Exclusion Criteria:

  • Phase 1 exclusions:

    • Failure to meet any of the above eligibility criteria
    • Use of video games for more than 2 hours/week over the previous 2 years
    • Currently engaged in a cognitive program such as Brain HQ or Lumosity
  • Phase 2 exclusion:

In addition to Phase 1 exclusion, also criteria below:

• Inability or unwillingness to travel to Clemson to provide two in-person blood samples at baseline and posttest

Sites / Locations

  • Clemson University Institute for Engaged AgingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

No contact

TDD1

TDD2

TDD1 + TDD2

BUD1

BUD2

BUD1 + BUD2

BUD2 + TDD2

BUD1 + TDD1

BUD2 + TDD1

BUD2 + TDD1 + TDD2

BUD1 + TDD2

BUD1 + TDD1 + TDD2

BUD1 + BUD2 + TDD2

BUD1 + BUD2 + TDD1

BUD1 + BUD2 + TDD1 + TDD2

CSA10

CSA20

CSA30

CSA40

Arm Description

0 hours of activities during intervention period of study

10 hours of top-down driven cognitive training games

10 hours of top-down driven cognitive training games

20 hours of top-down driven cognitive training games

10 hours of bottom-up driven cognitive training games

10 hours of bottom-up driven cognitive training games

20 hours of bottom-up driven cognitive training games

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games

10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games

20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games

20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games

10 hours of cognitive stimulating activities

20 hours of cognitive stimulating activities

30 hours of cognitive stimulating activities

40 hours of cognitive stimulating activities

Outcomes

Primary Outcome Measures

Protocol compliance
Participants complete laptop and phone activities as outlined in the study protocol

Secondary Outcome Measures

Complex Instrumental Activities of Daily Living
Measures of everyday functioning as detailed in the study protocol

Full Information

First Posted
May 4, 2022
Last Updated
May 4, 2022
Sponsor
Clemson University
Collaborators
National Institute on Aging (NIA), Penn State University, University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05366023
Brief Title
Elucidating the Necessary Active Components of Training
Acronym
ENACT
Official Title
Elucidating the Necessary Components and Mechanisms of Cognitive Training
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clemson University
Collaborators
National Institute on Aging (NIA), Penn State University, University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Loss of independence, cognitive decline, and difficulties in everyday function are areas of great concern for older adults and their families. Cognitive training is one low cost, noninvasive training intervention that has repeatedly demonstrated reliable transfer effects to maintained cognition, everyday function, health, and most recently, a 29% reduction in incident dementia. Importantly, many of these everyday function effects are maintained across five to ten years including: maintained driving mobility, 50% reduction in at-fault vehicle crashes, and maintained Instrumental Activities of Daily Living (IADL). Although clearly an important and effective intervention, the moderators and mechanisms underlying this program are unknown. The overall objective in this planning grant is to lay the conceptual and methodological foundation to explore cognitive, psychosocial, lifestyle behaviors, and biomarker mechanisms and moderators of two forms of conceptually driven cognitive training. Additionally, this study will examine how cognitive and psychosocial factors within daily life account for the transfer of cognitive training to everyday function. We will use a factorial design to randomize adults ages 55-85 to 0, 10, 20, 30, or 40 hours of two forms of cognitive training, a combined training, or an active comparison condition (Phase 1). An additional sample of participants will complete 20 hours of two forms of cognitive training or the active comparison group as well as provide blood samples (Phase 2). Across the study period, participants will complete cognitive, health, lifestyle, and psychosocial assessments at baseline, posttest, and approximately three month follow-up assessments in person or remotely using a study-provided laptop. Additionally, all participants will be asked to complete daily cognitive, health, lifestyle, and psychosocial measures daily using study-provided smartphones. This study will allow us to test the feasibility of our enrollment, assessment and training protocols for a future multisite clinical trial. This exploratory study is the first of its kind and will be used to provide important data relevant to a future larger randomized controlled trial examining mediators of cognitive training in a representative sample of adults. This information will assist in the future development of more effective home- and community-based interventions that maintain everyday function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Change, Cognitive Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No contact
Arm Type
No Intervention
Arm Description
0 hours of activities during intervention period of study
Arm Title
TDD1
Arm Type
Experimental
Arm Description
10 hours of top-down driven cognitive training games
Arm Title
TDD2
Arm Type
Experimental
Arm Description
10 hours of top-down driven cognitive training games
Arm Title
TDD1 + TDD2
Arm Type
Experimental
Arm Description
20 hours of top-down driven cognitive training games
Arm Title
BUD1
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games
Arm Title
BUD2
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games
Arm Title
BUD1 + BUD2
Arm Type
Experimental
Arm Description
20 hours of bottom-up driven cognitive training games
Arm Title
BUD2 + TDD2
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Arm Title
BUD1 + TDD1
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Arm Title
BUD2 + TDD1
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Arm Title
BUD2 + TDD1 + TDD2
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Arm Title
BUD1 + TDD2
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Arm Title
BUD1 + TDD1 + TDD2
Arm Type
Experimental
Arm Description
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Arm Title
BUD1 + BUD2 + TDD2
Arm Type
Experimental
Arm Description
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Arm Title
BUD1 + BUD2 + TDD1
Arm Type
Experimental
Arm Description
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
Arm Title
BUD1 + BUD2 + TDD1 + TDD2
Arm Type
Experimental
Arm Description
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
Arm Title
CSA10
Arm Type
Active Comparator
Arm Description
10 hours of cognitive stimulating activities
Arm Title
CSA20
Arm Type
Active Comparator
Arm Description
20 hours of cognitive stimulating activities
Arm Title
CSA30
Arm Type
Active Comparator
Arm Description
30 hours of cognitive stimulating activities
Arm Title
CSA40
Arm Type
Active Comparator
Arm Description
40 hours of cognitive stimulating activities
Intervention Type
Behavioral
Intervention Name(s)
BUD1
Intervention Description
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
Intervention Type
Behavioral
Intervention Name(s)
BUD2
Intervention Description
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
Intervention Type
Behavioral
Intervention Name(s)
TDD1
Intervention Description
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
Intervention Type
Behavioral
Intervention Name(s)
TDD2
Intervention Description
10 hours of top-down driven computerized cognitive training designed to improve executive function
Intervention Type
Behavioral
Intervention Name(s)
CSA10
Intervention Description
10 hours of computerized games
Intervention Type
Behavioral
Intervention Name(s)
CSA20
Intervention Description
20 hours of computerized games
Intervention Type
Behavioral
Intervention Name(s)
CSA30
Intervention Description
30 hours of computerized games
Intervention Type
Behavioral
Intervention Name(s)
CSA40
Intervention Description
40 hours of computerized games
Primary Outcome Measure Information:
Title
Protocol compliance
Description
Participants complete laptop and phone activities as outlined in the study protocol
Time Frame
Baseline through 3 month follow-up visit
Secondary Outcome Measure Information:
Title
Complex Instrumental Activities of Daily Living
Description
Measures of everyday functioning as detailed in the study protocol
Time Frame
Baseline through 3 month follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Phase 1: Age 55-85 community-dwelling adults Written informed consent obtained No reported evidence of or diagnosis of dementia/Alzheimer's Disease; score of 5 or greater on the MIS-t administered during phone screening Willing and able to participate in the up to 9 months of the study duration Is proficient in written and spoken English Phase 2: All Phase 1 criteria plus willingness and ability to provide two blood samples at baseline and posttest Exclusion Criteria: Phase 1 exclusions: Failure to meet any of the above eligibility criteria Use of video games for more than 2 hours/week over the previous 2 years Currently engaged in a cognitive program such as Brain HQ or Lumosity Phase 2 exclusion: In addition to Phase 1 exclusion, also criteria below: • Inability or unwillingness to travel to Clemson to provide two in-person blood samples at baseline and posttest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lesley Ross, PhD
Phone
864-916-6220
Email
Laross@clemson.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Shields, MS
Phone
864-916-6220
Email
jnshiel@clemson.edu
Facility Information:
Facility Name
Clemson University Institute for Engaged Aging
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Shields, MS
Phone
864-916-6220
Email
jnshiel@clemson.edu

12. IPD Sharing Statement

Learn more about this trial

Elucidating the Necessary Active Components of Training

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